BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27

    MDR report key: 18977238 · Received March 26, 2024

    Report

    Report Number
    3005180920-2024-00151
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728102
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 MARCH 2024: LOT 2003768A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2021. EXPIRATION DATE: 2026-JAN-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 6 MARCH 2024 REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452) LOT 2215288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2022. EXPIRATION DATE: 2027-OCT-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT 2236659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2022. EXPIRATION DATE: 2027-OCT-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) 2240571: 50 ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2022. EXPIRATION DATE: 2027-NOV-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 2115608: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2027-JAN-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2212556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2022. EXPIRATION DATE: 2027-OCT-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT 2217130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 2027-AUG-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVERSE SHOULDER REVISION SURGERY ON THE LEFT SIDE ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY. EXPLANTATION OF ALL REVERSE SHOULDER IMPLANTS FROM THE PRIMARY SURGERY. MELTED BONE GRAFT AND PRESENCE OF MACROSCOPICALLY INFECTED TISSUE. IMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434085 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 2003768A 07630040728102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention